D.C. Week: Gottlieb Pledges 'Vigorous Enforcement' of E-Cigs

Also: HHS secretary hospitalized, released, readmitted

WASHINGTON -- FDA Commissioner Scott Gottlieb, MD, withstood criticism from some lawmakers for his agency's "silence" on e-cigarettes. But Gottlieb pledged the FDA will soon be "stepping into this fight."

"We're going to have to step in ... We can't just addict a whole generation of young people on nicotine with e-cigarettes and consider that a public health advance," Gottlieb said Tuesday to a subcommittee of the House Committee on Appropriations. "We'll be taking some very vigorous enforcement steps ... starting in the coming weeks."

During the hearing on the FDA budget, subcommittee members stressed that the agency must act quickly to stop kids and teenagers from using e-cigarettes.

Rep. Nita Lowey (D-N.Y.), the top Democrat for the full Committee on Appropriations, raised a small rectangular device in her hand and said "Commissioner Gottlieb, what does this look like to you?"

Up to 59% of the U.S. population is comprised of people who are typically not included in clinical trials -- children, the elderly, and people with intellectual or physical disabilities, Catherine Spong, MD, deputy director of the National Institute for Child Health and Human Development, in Bethesda, Maryland, said Monday at a public workshop on evaluating inclusion and exclusion criteria in clinical trials. "If you look at all of these groups that are underrepresented ... a minority of people are included in research that's providing the evidence we so desperately need to help determine how to take care of people, so I think it's really important for us to take note."

"We clearly have the ability to include [these groups] but how do we make sure that actually happens, and how do we do that in a responsible way?" she asked. "[It's not right] to exclude someone just because it's not an easy population to deal with, or it's not an easy population to get consent for, or for a reason that might not be medically appropriate."

HHS Secretary Alex Azar Hospitalized, Released, Readmitted

Alex Azar, JD, Secretary of the Department of Health and Human Services was hospitalized on Sunday, and "treated with intravenous antibiotics" for what was thought to be a minor infection, according to a statement from the department. An "abundance of caution" was the reason for inpatient treatment.

On Monday afternoon Azar was discharged from St. Vincent's Hospital in Indianapolis, Ind. Two days later, the Secretary was readmitted for "further treatment and observation" of diverticulitis, reported The Washington Post.

Diverticulitis occurs when small pouches in the colon become inflamed or infected, The Post reported. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a friend of Azar's said the Secretary told him early Wednesday that doctors "didn't think there was any need for surgery," Fauci told the Post.

Azar was released from the hospital Thursday afternoon and is said to be recovering at home with his family.

"His doctors have advised him to rest in order to ensure a full recovery, and it is unlikely that he will be returning to D.C. until sometime next week," said an HHS spokesperson in an email on Friday. "As previously stated, he remains engaged with the responsibilities of running the department."

The FDA is now expected to decide the medication's fate by late June, according to Justin Gover, CEO of GW Pharmaceuticals, which manufactures Epidiolex. If approved, Epidiolex would become the first medication derived from the cannabis plant allowed in the U.S.

"We are reviewing this application on an expedited timeline," an FDA representative said after the committee vote, "working to accelerate this process as much as we can."

Advocates celebrated the committee vote.

"Despite significant therapeutic advances in the last few years," the Epilepsy Foundation said in a statement issued shortly after the meeting, "there is a great unmet need in the epilepsy community, as more than a third of people living with epilepsy do not have seizure control, and many more live with significant side effects that impact cognitive ability, mood, and memory ... Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies."

"I think that the opioid manufacturers, through twisted research, deceptive marketing, and bought-and-paid-for advocacy work, had a significant role to play in creating and fueling the crisis," said the Senate Finance Committee's ranking member, Ron Wyden (D-Ore.).

He criticized the written testimony of Brett Giroir, MD, Health and Human Services Assistant Secretary for Health, a pediatrician, former medical school executive, and a witness at the hearing, for neglecting to address the role of drug companies in sparking the crisis.

When Wyden described what he saw as greed and manipulation by drug companies, and asked whether Giroir shared those concerns, Giroir punted.

"There was a confluence of factors that led to this. Clearly, opioids were overprescribed ... by well-intentioned physicians, who believed they were doing the best for the patients," Giroir said. "How we got here and who is responsible, I think is a matter for the the committee and others."

Next Week

On Monday, an FDA advisory committee will take a new look at the potential rheumatoid arthritis drug baricitinib.

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